Xarelto Coverage1

Traditional and Online Media Coverage

1. Missing Data from Rivaroxaban Letter Draws Speculation, Criticism

   Mar 3, 2016 | NEJM Journal Watch

   By Amy Orciari Herman
   
   
   A letter published in the New England Journal of Medicine in February — asserting that a faulty device did not influence the safety and efficacy outcomes for the anticoagulant rivaroxaban (Xarelto) in the ROCKET AF trial — did not include laboratory data that could have been used to evaluate the device's accuracy, the New York Times reports.
2. Health Brief: Trump Offers Some Health Plan Details

   Mar 3, 2016 | Morning Consult

   By Mary Ellen Mcintire
   
   
   Document Claims Drug Makers Deceived a Top Medical Journal Katie Thomas, The New York Times It is a startling accusation, buried in a footnote in a legal briefing filed recently in federal court: Did two major pharmaceutical companies, in an effort to protect their blockbuster drug, mislead editors at one of the world’s most prestigious medical journals?

Traditional and Online Media Coverage

1. Missing Data from Rivaroxaban Letter Draws Speculation, Criticism

   Mar 3, 2016 | NEJM Journal Watch

   By Amy Orciari Herman

   A letter published in the New England Journal of Medicine in February — asserting that a faulty device did not influence the safety and efficacy outcomes for the anticoagulant rivaroxaban (Xarelto) in the ROCKET AF trial — did not include laboratory data that could have been used to evaluate the device's accuracy, the New York Times reports.

   The letter in question was written mainly by researchers from Duke University, who'd been hired by Johnson & Johnson and Bayer to run ROCKET AF.

   The lab data in question are comparisons between patients' international normalized ratios as measured by the point-of-care device and results of tests performed at a central laboratory. The device was later recalled by the FDA because it often gave falsely low INR readings.

   Asked to comment, a spokesperson for the New England Journal of Medicine said, "During the editing process ... the editors told the authors that they would like to see a systematic evaluation of routinely obtained central laboratory INR data but assumed that such data did not exist. This was affirmed by the authors and was the case. Only two data points existed for a subset of the study population. Without a substantial majority of paired values, a comparison between the two methods would not be clinically directive."

   Lawyers representing patients suing the drug makers over rivaroxaban's safety say the companies intentionally stayed silent about the data while "in the midst of providing the very same data to regulators in the United States and Europe," the Times reports.

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2. Health Brief: Trump Offers Some Health Plan Details

   Mar 3, 2016 | Morning Consult

   By Mary Ellen Mcintire

   Document Claims Drug Makers Deceived a Top Medical Journal
   Katie Thomas, The New York Times

   It is a startling accusation, buried in a footnote in a legal briefing filed recently in federal court: Did two major pharmaceutical companies, in an effort to protect their blockbuster drug, mislead editors at one of the world’s most prestigious medical journals?

   Return to headline | Return to top